← All drugs
Drug

Decitabine

140 flagged reaction(s) · 7,492 total co-reports · max PRR 77.3
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Acute Myeloid Leukaemia 240 77.3 81.9 signal
2 Myelosuppression 372 54.6 59.8 signal
3 Febrile Neutropenia 455 34.2 38.2 signal
4 Myelodysplastic Syndrome 88 30.2 30.8 signal
5 Haematotoxicity 54 28.9 29.3 signal
6 Cytopenia 67 27.9 28.3 signal
7 Bone Marrow Failure 110 26.7 27.4 signal
8 Bacteraemia 62 26.2 26.5 signal
9 Therapy Partial Responder 48 15.8 16.0 signal
10 Hyperbilirubinaemia 31 14.9 15.0 signal
11 Pancytopenia 154 13.7 14.2 signal
12 Mucosal Inflammation 72 13.7 13.9 signal
13 Lung Infection 42 13.2 13.3 signal
14 Hospice Care 25 12.6 12.6 signal
15 Posterior Reversible Encephalopathy Syndrome 24 12.5 12.6 signal
16 Thrombocytopenia 240 10.7 11.2 signal
17 Neutropenia 287 10.5 11.2 signal
18 Therapy Non-responder 92 10.2 10.4 signal
19 Septic Shock 86 9.8 10.0 signal
20 Clostridium Difficile Colitis 21 9.8 9.8 signal
21 Sepsis 206 9.1 9.6 signal
22 Haemorrhage Intracranial 26 8.6 8.6 signal
23 Neutrophil Count Decreased 66 8.1 8.2 signal
24 Respiratory Failure 117 7.9 8.1 signal
25 Disease Progression 189 7.9 8.3 signal
26 Bacterial Infection 29 7.7 7.8 signal
27 Skin Infection 17 7.5 7.6 signal
28 Leukocytosis 27 7.4 7.4 signal
29 Leukaemia 14 7.3 7.4 signal
30 Agranulocytosis 27 7.2 7.3 signal
31 Platelet Count Decreased 154 7.2 7.4 signal
32 Transfusion 15 7.1 7.1 signal
33 Cardiomyopathy 21 7.0 7.1 signal
34 Acute Respiratory Failure 27 7.0 7.0 signal
35 Drug Resistance 36 6.9 7.0 signal
36 Blood Count Abnormal 21 6.8 6.8 signal
37 Thrombotic Microangiopathy 13 6.6 6.7 signal
38 Gingival Bleeding 18 6.5 6.5 signal
39 Infection 178 6.1 6.3 signal
40 Multiple Organ Dysfunction Syndrome 34 6.0 6.1 signal
41 Full Blood Count Decreased 24 5.9 5.9 signal
42 White Blood Cell Count Decreased 128 5.8 6.0 signal
43 Device Related Infection 18 5.8 5.8 signal
44 Disseminated Intravascular Coagulation 16 5.6 5.6 signal
45 Fungal Infection 37 5.5 5.5 signal
46 Splenomegaly 13 5.5 5.5 signal
47 Red Blood Cell Count Decreased 31 5.4 5.4 signal
48 Pneumonitis 29 5.3 5.3 signal
49 Petechiae 11 5.2 5.2 signal
50 Ileus 13 5.2 5.2 signal
51 Hypoxia 36 5.1 5.1 signal
52 Neoplasm Progression 36 5.1 5.1 signal
53 Pneumonia 319 4.9 5.2 signal
54 Tooth Abscess 10 4.8 4.8 signal
55 Drug Ineffective For Unapproved Indication 54 4.8 4.8 signal
56 Ventricular Tachycardia 16 4.8 4.8 signal
57 Acute Respiratory Distress Syndrome 17 4.8 4.8 signal
58 Blood Bilirubin Increased 26 4.7 4.8 signal
59 Disease Recurrence 45 4.7 4.7 signal
60 Haemoglobin Decreased 97 4.7 4.7 signal
61 Supraventricular Tachycardia 9 4.7 4.7 signal
62 Liver Injury 22 4.5 4.5 signal
63 Hypophagia 23 4.5 4.5 signal
64 Candida Infection 15 4.4 4.5 signal
65 Product Use In Unapproved Indication 218 4.4 4.6 signal
66 Anaemia 167 4.3 4.5 signal
67 Cardiac Failure 70 4.3 4.4 signal
68 Electrolyte Imbalance 10 4.3 4.3 signal
69 Hypomagnesaemia 12 4.3 4.3 signal
70 Blood Test Abnormal 12 4.2 4.2 signal
71 Subdural Haematoma 12 4.1 4.1 signal
72 Colitis 31 4.1 4.1 signal
73 Hypocalcaemia 15 3.9 3.9 signal
74 Lymphocyte Count Decreased 14 3.9 3.9 signal
75 Leukopenia 39 3.9 3.9 signal
76 Body Temperature Increased 16 3.9 3.9 signal
77 Drug-induced Liver Injury 24 3.8 3.9 signal
78 Platelet Count Increased 10 3.8 3.8 signal
79 Mouth Ulceration 16 3.8 3.8 signal
80 Malignant Neoplasm Progression 77 3.7 3.8 signal
81 Staphylococcal Infection 25 3.7 3.7 signal
82 Appendicitis 7 3.7 3.7 signal
83 Pyrexia 260 3.7 3.9 signal
84 Immunodeficiency 11 3.7 3.7 signal
85 Gastrointestinal Haemorrhage 61 3.6 3.6 signal
86 Pneumocystis Jirovecii Pneumonia 7 3.5 3.5 signal
87 Cytokine Release Syndrome 13 3.4 3.4 signal
88 Hepatic Function Abnormal 25 3.3 3.3 signal
89 Pleural Effusion 41 3.3 3.3 signal
90 Pulmonary Oedema 30 3.3 3.3 signal
91 Haematocrit Decreased 13 3.2 3.2 signal
92 Mental Status Changes 18 3.2 3.2 signal
93 No Therapeutic Response 8 3.2 3.2 signal
94 Blood Alkaline Phosphatase Increased 16 3.2 3.2 signal
95 Sinus Tachycardia 9 3.1 3.1 signal
96 Melaena 14 3.1 3.1 signal
97 Hepatotoxicity 14 3.1 3.1 signal
98 Haemorrhoids 12 3.0 3.0 signal
99 Renal Tubular Necrosis 6 3.0 3.0 signal
100 Pericarditis 10 3.0 3.0 signal
101 Palmar-plantar Erythrodysaesthesia Syndrome 14 3.0 3.0 signal
102 Alanine Aminotransferase Increased 36 2.9 2.9 signal
103 Off Label Use 501 2.9 3.1 signal
104 Multi-organ Failure 10 2.8 2.8 signal
105 Blood Lactate Dehydrogenase Increased 9 2.8 2.8 signal
106 Tooth Extraction 7 2.8 2.8 signal
107 Cellulitis 28 2.7 2.8 signal
108 Clostridium Difficile Infection 12 2.7 2.7 signal
109 White Blood Cell Count Increased 21 2.7 2.7 signal
110 Cytomegalovirus Infection 9 2.7 2.7 signal
111 Tooth Infection 7 2.6 2.6 signal
112 Myocarditis 6 2.6 2.6 signal
113 Atrial Fibrillation 50 2.5 2.6 signal
114 Acute Myocardial Infarction 15 2.5 2.5 signal
115 Pericardial Effusion 11 2.4 2.4 signal
116 Fluid Overload 7 2.3 2.3 signal
117 Full Blood Count Abnormal 5 2.3 2.3 no signal
118 Diverticulitis 13 2.3 2.3 signal
119 Renal Failure Acute 20 2.3 2.3 signal
120 Orthostatic Hypotension 8 2.3 2.3 signal
121 Treatment Failure 37 2.2 2.2 signal
122 Therapeutic Response Decreased 27 2.2 2.2 signal
123 Hepatic Failure 13 2.1 2.1 signal
124 Vasculitis 5 2.1 2.1 no signal
125 Haematoma 11 2.1 2.1 signal
126 Bronchospasm 6 2.1 2.1 no signal
127 Diabetic Ketoacidosis 10 2.1 2.1 signal
128 Interstitial Lung Disease 19 1.9 1.9 no signal
129 Subarachnoid Haemorrhage 4 1.9 1.9 no signal
130 Abscess 6 1.9 1.9 no signal
131 Haemorrhage 35 1.7 1.7 no signal
132 Death 285 1.6 1.7 no signal
133 Osteonecrosis Of Jaw 8 1.6 1.6 no signal
134 Mydriasis 4 1.5 1.5 no signal
135 Neurotoxicity 5 1.4 1.4 no signal
136 Lactic Acidosis 9 1.4 1.4 no signal
137 Fistula 3 1.3 1.3 no signal
138 Circumstance Or Information Capable Of Leading To Medication Error 7 1.0 1.0 no signal
139 Drug Effective For Unapproved Indication 6 1.0 1.0 no signal
140 Product Storage Error 10 0.6 0.6 no signal